Support for a Paediatric Investigation Plan in the European Union, for a US-based client

Marketing Communication
Regulatory affairs Pharmaceutical industry
Regulatory affairs Pharmaceutical industry
May 18, 2022
  • Drug Development
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BlueReg supported a US-based client with a European Paediatric Investigation Plan (PIP) for their product. BlueReg initially provided guidance with the paediatric regulatory strategy and its potential impact on the PIP Application positioning. Subsequently, BlueReg wrote the PIP Scientific Document and prepared the ready-for-submission PIP Application.

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